Agilis Consulting Adds Former FDA Human Factors Regulator to Executive Team

PHOENIX, Jan. 4, 2021 /PRNewswire/ -- Agilis Consulting Group, a full-service medical human factors firm that helps new and established companies achieve successful human factors submissions, has named Shannon Hoste as Sr. Director, Human Factors and Regulatory Strategy.

"Shannon's unparalleled industry and regulatory experience will significantly enhance our pre-market and post-market human factors and risk management client services," said Pat Patterson, President & CEO of Agilis Consulting Group. "In over 20 years, no regulatory agency has ever rejected the human factors strategy from an Agilis client. Shannon will build upon this performance and provide our clients with world-class human factors regulatory and program strategy. The entire Agilis Team is thrilled to welcome her aboard."

Shannon brings over 20 years in the medical device, pharmaceutical and in vitro diagnostic industries. Together with her FDA regulatory experience in both CDRH and CDER, where she provided oversight to hundreds of human factors submissions, she is a recognized expert in risk management and product development. In her new role, Shannon will lead a high-performance team of experienced human factors, biomedical engineers and instructional design experts to support Agilis' US and global clients from early-stage user research, through regulatory submission and post-market surveillance.

"It is an honor to have joined Agilis and Pat Patterson's team. I am looking forward to supporting this amazing group and our clients' continued success in 2021 and beyond,"  Shannon expressed upon joining.

As a leader, Shannon has previously architected product development, human factors, and risk management processes within medical device companies from start-up to Fortune 100. As an engineer, she has developed, launched, and sustained combination products, medical devices and IVDs. With this, she brings to Agilis, and their clients, a holistic understanding of product life-cycle needs.

About Agilis Consulting Group
Agilis Consulting Group is a full-service human factors firm exclusively serving the medical industry. Agilis services include human factors strategy consulting, early user research to late stage and post-market human factors studies while navigating the complex global regulatory landscape, resulting in safe and effective medical products being brought to market. Agilis' proven human factors strategies, process and expertise drives regulatory success and speed to market – the first time. To learn how Agilis can support your medical device or combination product human factors success, please contact [email protected] or visit us at www.agilisconsulting.com

SOURCE Agilis Consulting Group

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